Special Investigation of Vfend on Scedosporisis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 13
- 主要终点
- Number of Participants With Serious Treatment Related Adverse Events.
研究概览
简要总结
To collect the efficacy and safety information of voriconazole related to their appropriate use in daily practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female patients who are prescribed voriconazole (VFEND) for deep mycosis on Scedosporisis.
排除标准
- •Subject who have been prescribed voriconazole (VFEND) for deep mycosis on Aspergillus, Candidasis,Cryptococcal infections not involving Scedosporisis.
研究组 & 干预措施
Voriconazole
Subjects who are treated with voriconazole
干预措施: Voriconazole (Drug)
结局指标
主要结局
Number of Participants With Serious Treatment Related Adverse Events.
时间窗: 16 weeks
Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Serious adverse events were defined as those including death, fatal risk, hospitalization or prolongation of hospitalization period, continuous dysfunction, those causing malformation, and serious ones like the above-cited events. Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.
次要结局
- Number of Participants With Clinical Response of Cure at the Test-of-Cure(TOC) Visit.(16 weeks)